General Manager - Medical Device Manufacturing Operations

Job Title: General Manager Works

Location: Ahmedabad
Department: Manufacturing Operations
Reporting To: Managing Director / CEO

Job Summary:

The General Manager Works will oversee the entire operations of a sterile medical device manufacturing facility. This includes responsibility for production, quality assurance, engineering, maintenance, supply chain, regulatory compliance, EHS, and continuous improvement. The role ensures alignment with regulatory standards (e.g., ISO 13485, US FDA 21 CFR Part 820, EU MDR) and drives operational efficiency, product quality, and team performance.

Key Responsibilities:

Facility Setup & Commissioning

• Lead greenfield project execution, including site layout, utility planning, cleanroom design (ISO Class 8/Class 7), and equipment selection.
• Ensure validation and qualification of facility, equipment (product assembling siliconization, assembly, and ETO sterilization systems), and processes (IQ/OQ/PQ).
• Work closely with architects, consultants, and vendors to deliver facility setup on time and within budget.

Operations Management

• Lead and manage all aspects of manufacturing operations in a cleanroom and sterile environment (Class 100, 1000, 10,000 as applicable).
• Ensure compliance with cGMP, ISO 13485, FDA, and other relevant regulations.
• Oversee planning, scheduling, and execution of production to meet delivery timelines and cost targets.
• Implement Lean Manufacturing and Six Sigma practices for productivity and waste reduction.

Quality & Regulatory Compliance

• Work closely with the Quality Assurance and Quality Control teams to ensure that all products meet internal and regulatory standards.
• Ensure documentation and traceability in compliance with QMS.
• Act as site lead during regulatory inspections and audits (US FDA, ISO, CDSCO, etc.).
• Develop and enforce SOPs for cleanroom practices, contamination control, and batch record documentation.
• Lead site readiness for audits by regulatory authorities and notified bodies.

Engineering & Maintenance

• Ensure efficient functioning and preventive maintenance of manufacturing equipment and utilities (HVAC, water systems, sterilizers, etc.).
• Drive validation of equipment, processes, and facilities.

Supply Chain & Procurement

• Oversee raw material procurement, inventory management, and vendor coordination.
• Ensure cost-effective and timely procurement of components and consumables.
• Manage logistics and distribution for finished goods.

Team Leadership & Development

• Recruit, train, and mentor production, quality, engineering, and support staff
• Build a strong culture of safety, quality, and continuous improvement.
• Establish KPIs and drive operational excellence through lean principles and Six Sigma tools.
• Lead cross-functional teams including production, QA, engineering, and EHS.
• Drive performance management, training, and succession planning.
• Foster a culture of accountability, safety, and continuous improvement.

Budgeting & Strategic Planning

• Prepare and manage operational budgets, CAPEX and OPEX forecasts.
• Develop strategic plans for capacity expansion, new product introductions, and automation.

Required Qualifications:

• Bachelor's degree in Engineering (Mechanical, Biomedical, or Industrial preferred).
• Postgraduate qualification in Business Administration or Operations Management is a plus.
• 1520 years of experience in manufacturing, with at least 810 years in sterile medical device production.
• Proven track record in leading plant operations in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Strong knowledge of cleanroom operations, sterilization (ETO, Gamma, Steam), validation protocols, and QMS.

Key Skills:

• Leadership & strategic thinking
• Regulatory knowledge (ISO, FDA, CE, MDR)
• Operational excellence (Lean, Six Sigma)
• Financial acumen
• Excellent communication and stakeholder management
• Risk management and problem-solving